Job Type: Perm
Job ID: JO-1908-19282
Consultant: Karen McHugh
Do you have at least 3 years’ experience in Pharma Manufacturing including technology transfer preferably in the biopharmaceutical / bioprocessing field?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Aseptic Process Specialist- Tech Transfer - Dublin West - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their Irish plants, this is an exciting time to join the team
Part of the cross-functional technology transfer team with the scope of regenerative medicine manufacturing
Tracking activities on the Tech Transfer Schedule
Liaise with QC, QA, Development Scientists, CAPEX, Logistics, Supply Chain and Manufacturing to ensure adherence to schedule and efficient troubleshooting
Understand regulatory requirements associated with cell culture manufacturing and communicate them to the project and operations team.
Planning, implementation and evaluation of experimental programs with regard to the manufacturing process incl. design of experiment, continuous process verification and process capability evaluation.
Assist with the process validation and tech transfer runs.
Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.
Accompany and supervise development, transfer, validation and process optimization operations in an aseptic manufacturing environment.
Safeguard the timely and GMP compliant production of registration samples.
Complete required documentation and change controls relating to technology transfer, development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) Technology Transfer Plan, BMRs, SOP, Logbooks and EOPs.
Manufacturing and process subject matter expert with regard to aseptic manufacturing, bioprocessing and regenerative medicines ; Participate in and support regulatory audits
Support investigations in manufacturing and technical deviations.
Ensure that appropriate validations are in place in the area of responsibility (e.g. process validation, cleaning validation, aseptic validation)
Execute, lead and participate in risk assessments associated with technology transfer of the process.
Support a culture of open communication, fairness and transparency.
Participate in any required training and ensure team members are suitably trained..
Advocate team problem solving. Working proactively to positively affect metrics, morale and metrics such as schedule adherence and quality attributes
Drive the implementation of Standard Work amongst team ensuring activities are coordinated and integrated (training, documentation, process improvements, investigation activities etc.) using an inclusive planning system.
Uphold Company Code of Conduct.
Foster a safe work environment, ensuring all colleagues maintain safety as a priority.
Travel requirements: Up to 20% during project phase.
Science, Engineering or BioChemistry degree or other relevant field of expertise.
At least 3 years’ experience in Pharma Manufacturing including technology transfer preferably in the biopharmaceutical / bioprocessing field.
Detailed and in-depth knowledge of biopharmaceutical manufacturing operations, as well as Quality and Regulatory Affairs.
Detailed knowledge in experimental design, statistical data analysis and quality by design
Excellent trouble shooting and problem-solving skills
Promoting a culture where diversity and inclusion is part of the DNA of the site
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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